ISPE – Turkey Affiliate

ISPE Turkey Affiliate
"QbD & PAT" Workshop
13 March 2017

ISPE Turkey Affiliate's QbD* & PAT** Workshop will be held on 13th of March, 2017 at Santa Farma Pharmaceuticals.

We wish to be together at the workshop where QbD and PAT concepts and applications will be discussed throughout the presentations of Our Vice-Chair and QbD & PAT Working Group Leader Assoc. Prof. Buket Aksu and Bayer Turkey Quality Project Manager Mehmet Çalıkoğlu.

*QbD: Quality by Design
**PAT: Process Analytical Technologies

PS: ISPE membership is a prerequisite for participation to the workshop.

Program (In Turkish)
Location (In Turkish)


ISPE Turkey Affiliate met with the students of Kadırga Vocational School!


The first of the seminars for 2017 in the scope of ISPE Turkey Affiliate’s cooperation with Kadırga Vocational School was conducted by Our Board Member Figen Ergin on 1st of March 2017.

Within the scope of the seminar, GMP concepts were introduced and discussions were made around the questions of “What is GMP? Why is GMP important in drug manufacturing?" with the students.


ISPE Turkey Affiliate
“Data Integrity Key for GMP Compliance” Workshop
23 February 2017


The third workshop of “Data Integrity Key for GMP Compliance” working group founded in 2016 within the ISPE Turkey Affiliate was held on February 23, 2017 at Hilton Kozyatağı, Istanbul with broad participation from the pharmaceutical industry.

The workshop started with opening remarks of Fatma Taman (ISPE), Nadi Tanca (BTS) and Timur Kabadayı (Conval Group); then continued with our working group leader Figen Ergin’s presentation on data integrity guidelines and previous studies. Data Integrity Risk Inventory preparation studies were performed in an interactive group study fashion during the afternoon session of the workshop.

We would like to thank BTS and Conval Group for their sponsorships as well as all our attendees for their contributions. We look forward to working together in future workshops and seminars on this topic.


ISPE Turkey Affiliate
“Data Integrity Key for GMP Compliance” Workshop
23 February 2017

The third workshop of ISPE Turkey Affiliate “Data Integrity Key for GMP Compliance” working group will be held on February 23, 2017 at Hilton Kozyatağı, Istanbul.

Following information exchange on data integrity guides and previous studies, the workshop will continue with studies for Data Integrity Risk Inventory. We look forward to your attendance.

PS: ISPE membership is a prerequisite for participation to the workshop.

Program (In Turkish)
Location (In Turkish)


ISPE Turkey Affiliate at CPhI Istanbul Exhibition!


CPhI Istanbul which will gather again regional drug manufacturers, suppliers, solution and technology providers will be held on 8-10 March 2017 at Istanbul Expo Center (IFM), Istanbul - Turkey.

Following the record number of participants and visitors in 2016, CPhI Istanbul 2017 continues to serve as a unique forum for domestic and foreign pharmaceutical industry representatives and ISPE Turkey Affiliate will contribute to the exhibition with a booth and two workshop sessions.

The workshop on “Importance of API for Registration and Regulatory Requirements for API Variations” leaded by Nezihe İçduygu will take place at the Seminar Area on 9 March, 2017 Thursday (15:00-17:00) and the workshop about “What is Quality by Design (QbD)? Associated Regulations and Its Importance for APIs” organised by Assoc. Prof. Buket Aksu will be held on 10 March, 2017 Friday (14:00-16:00).

You are also invited to ISPE Turkey Affiliate booth during the exhibition (Booth number: 10G11).

For more information about the exhibition and conference: http://www.cphi.com/istanbul/
For registration: https://registration.n200.com/survey/3h182g05p4k1y


ISPE Turkey Affiliate at Cleanroom 2017 Exhibition


The Cleanroom Technology, Maintenance and Equipment 2017 Exhibition which will bring together the Facility managers and Cleanroom professionals who design and engineer extraordinary spaces for facilities will be held on 20-22 April 2017 in ICEC – Lütfi Kırdar International Congress and Exhibition Center, Istanbul.

Cleanroom Exhibition is going to be much more fruitful since the exhibition will be organised at the same time, at the same venue with Biotech Eurasia - Biotechnology and Life Sciences Exhibition and Expo Analytec - Analysis Technology and Laboratory Equipment Exhibition.

Within the exhibition that will provide a holistic approach with integrated “CBA High Technology Show” concept, you are invited to Anel Group Mechanical Design Coordinator Nejat Babür’s presentation on “ISPE and Energy Efficient Cleanroom Design” on 21 April 2017 Friday at Aspendos Hall (13:00 – 13:40) as well as ISPE Turkey Affiliate booth (Booth no: 510) during the entire exhibition.

For more information about the exhibition: http://www.expocleanroom.com/index.php?language_code=en


ISPE 2017 Europe Annual Conference
“Lead and Manage Future Operations”
3-5 April 2017, Barcelona


ISPE 2017 Europe Annual Conference with the theme of “Lead and Manage Future Operations” will be held on 3-5 April 2017 in Barcelona, Spain.

This year the conference will focus on “Pharma Manufacturing 2025” and the way to achieve a modern, agile and flexible production landscape with the topics like Continuous Manufacturing, Sterile and Aseptic Manufacturing, Active Pharmaceutical Ingredients, Regulatory Updates for the Commercial and Clinical Supply Chain, Mass Serialisation and Investigational Products.

Prominent questions like “What will the main regulatory trends be by 2025?, How will the current technology platforms evolve?, What will the required skillsets and capabilities of the future workforce be?, What does the facility of the future look like and how will operations be managed?, How can we guarantee safe supply: no counterfeits, no drug shortages?” will be explored and discussed during the conference.

Please visit the conference website for detailed information and registration: http://www.ispe.org/2017-europe-annual-conference


ISPE Turkey Affiliate Industry Gathering
“Engineering Approach at the Facilities of the Future”
26 January 2017


The third of “Industry Gatherings” that ISPE Turkey Affiliate organizes as afternoon meetings based on current issues was held on 26 January 2017 at The Grand Tarabya, Istanbul and covered the topic of “Engineering Approach at the Facilities of the Future”.

Following the presentation about “Engineering Approach at the Facilities of the Future” given by Anel Group Mechanical Design Coordinator Nejat Babür, Manufacturing Site Leader of Pfizer Turkey Devrim Çavuşoğlu gave information about the "Excellence in Pharma Engineering" Working Group established within ISPE Turkey Affiliate and working group’s road map for 2017 was created with the contributions of participants.

We hope to be together at the further organizations of our working group.


Pharmaceutical Engineering Conference, Amman – Jordan


Chair of ISPE Turkey Affiliate Fatma Taman, contributed to the Pharmaceutical Engineering Conference, organised by Agon Academy on 7-8 January 2017 in Amman – Jordan, with presentations on “Introduction to Pharmaceutical Project Management” and “Successful Purchasing/Procurement Approaches for Pharmaceutical Projects”.


ISPE Turkey Affiliate Industry Gathering
“Engineering Approach at the Facilities of the Future”
26 January 2017

The third of “Industry Gatherings” that ISPE Turkey Affiliate organizes as afternoon meetings based on current issues, will be held on 26 January 2017 at The Grand Tarabya, İstanbul and will cover the topic of “Engineering Approach at the Facilities of the Future”.

We hope to be together at our Industry Gathering where in addition to presentation on “Engineering Approach at the Facilities of the Future”, information will be provided about the "Excellence in Pharma Engineering" Working Group to be established within ISPE Turkey Affiliate in 2017.

Date: January 26, 2017 – Thursday
Time: 17:00-19:00
Location: The Grand Tarabya

Program (In Turkish)
ISPE Turkey Affiliate Young Professionals Group


ISPE Turkey Affiliate Young Professionals Group will be established in 2017 with the participation of individuals just starting in the pharmaceutical industry, one to four years after university graduation.

To access resources designed for Young Professionals and to develop business network, you can become a member of ISPE Young Professionals Group with a fee of 99 Euro instead of 149 Euro by taking advantage of discounted membership benefits.


“Quality & Metrics” 2nd Workshop
19 December 2016


The second workshop of our "Quality & Metrics” working group, founded within the ISPE Turkey Affiliate in 2016 and leaded by İlknur Gümüşeli Hırçın, was held in December 19, 2016 at Topkapı facility of Bayer Turkey.

Following the opening remarks of ISPE Turkey Affiliate Chair Fatma Taman and Board Member İlknur Gümüşeli Hırçın, Havva Çınar Aşar's presentation focused on quality metrics pilot programs and expectations of FDA and MHRA regarding quality metrics.

The highly attended workshop was concluded with the interactive evaluation of the views of participants to determine the issues to be discussed in future meetings.


“Quality Assurance” Seminar at Istanbul University Faculty of Pharmacy


Within the scope of the seminars organized by Istanbul University’s ISPE Student Chapter with the aim of introducing various working areas in the pharmaceutical industry to the Students of the Pharmaceutical Faculty, our Board Member Hülya Uslu gave a “Quality Assurance” themed seminar on 2 December, 2016.


ISPE Turkey Affiliate
“Quality & Metrics” 2nd Workshop
19 December 2016

The second workshop of our "Quality & Metrics” working group, founded within the ISPE Turkey Affiliate in 2016 and leaded by İlknur Gümüşeli Hırçın, will be held in December 19, 2016 at Topkapı facility of Bayer Turkey.

Within the scope of the workshop, our Board Member Havva Çınar Aşar's presentation will focus on quality metrics pilot programs and the expectations of FDA and MHRA regarding quality metrics. In addition, the topics to be discussed at future workshops will be assessed based on the evaluations of the participants.

We hope to be together at our interactive event.

Note: ISPE Membership is a pre-requisite for participation to the workshop.


Program (In Turkish) | Location (In Turkish)




“A Journey to the Pharmaceutical Facilities of the Future with the Vision of Industry 4.0” Seminar
25 November 2016


ISPE Turkey Affiliate’s 2016 Fall Seminar was held on 25 November 2016 at Barbaros Point Hotel – Istanbul with the theme of “A Journey to the Pharmaceutical Facilities of the Future with the Vision of Industry 4.0”.

The seminar started with opening remarks of Fatma Taman, Chair of ISPE Turkey Affiliate, and continued with "GMP Updates in the PIC/S Compliance Process" presentation of MSc. Pharm. Gülşen Yılmaz from the Inspection Vice Presidency of Turkish Medicines and Medical Devices Agency (TMMDA) who elaborated on TMMDA’s studies with regards to PIC/S membership application process.

Siemens Digital Factory Country Division Lead Ali Rıza Ersoy presented the concept of Industry 4.0 which was very well received by the audiance and Nejat Babür, Anel Group Mechanical Design Coordinator, shared his experience and knowledge via his presentation on the facilities of the future and new approaches for facility design.

The afternoon session of the seminar included Ecolab Life Sciences Unit Middle East Africa Manager Burcu Şeker’s presentation about Cleaning and Contamination Control in the Facilities of Future and Deloitte Health and Pharmaceutical Industry Leader Güler Hülya Yılmaz’s presentation on Health and Pharmaceutical Sector Predictions for the year of 2020.

The seminar was concluded with an interactive panel session where sectoral topics like biotechnology, PIC/S process, R&D studies were discussed with the contributions of Chair of Pharmaceutical Industry Association of Turkey (TISD) Cengiz Celayir, Secretary General of Pharmaceutical Manufacturers Association of Turkey (İEİS) Turgut Tokgöz and Secretary General of Association of Research-Based Pharmaceutical Companies (AİFD) Dr. Ümit Dereli.


Operational Excellence from ISPE’s Perspective


Chair of ISPE Turkey Affiliate Fatma Taman’s article titled as “Operational Excellence from ISPE’s Perspective” has been published in the 50th Special Issue of the Workshop Magazine.

Fatma Taman emphasized that operational excellence is a roof concept that aims doing more with less, taking into account all operational processes and integrating values including health and safety, environment and quality. From the perspective of the pharmaceutical industry which is based on advanced technology that needs to adapt scientific and technological developments rapidly, but on the other hand, can not compromise in quality, coupled with the fact that saving policies in pharmaceutical spending are an important matter in the agenda of public authorities, Ms. Taman pointed out that the improvements in the pharmaceutical sector are even more sensitive and important.

Fatma Taman referred to ISPE Turkey Affiliate’s seminars organized in order to enable the Turkish pharmaceutical industry to closely monitor the changes in the global platform via worldwide experts that contribute as speakers; also mentioned PAT (Process Analytical Technologies) working group which deals with the QbD (Quality by Design) topic that has a wide range of potential applications in the pharmaceutical industry and the PQLI (Product Quality Life Cycle Application) approach that aims to integrate quality into the whole lifecycle of the product and emphasized the great importance of all these activities in the context of Operational Excellence.

It was indicated that the topic of Operational Excellence will be discussed in the future Industry Gatherings planned by ISPE Turkey Affiliate as afternoon meetings which are enriched by experience sharing of speakers coming from different sectors, after having discussed current topics such as Data Integrity and Industry 4.0 so far. Further studies are also planned to be continued within the Excellence in Pharma Engineering Working Group which will be founded in 2017.


ISPE Turkey Affiliate
“A Journey to the Pharmaceutical Facilities of the Future with the Vision of Industry 4.0”
25 November 2016

ISPE Turkey Affiliate’s 2016 Fall Seminar will be held on 25 November 2016 at Barbaros Point Hotel – Istanbul around the theme of “Journey to the Pharmaceutical Facilities of the Future with the Vision of Industry 4.0”.

The concept of Industry 4.0 and 2020 predictions for the Health-Pharmaceutical Sector will be presented. Design and Contamination Approaches for Pharmaceutical and Biotechnological Facilities of the Future will also be discussed in conjunction with these developments.

Some of the speakers:

  • Siemens Digital Factory Country Division Lead
    Ali Rıza Ersoy
  • Deloitte Health and Pharmaceutical Industry Leader
    Güler Hülya Yılmaz
  • Anel Group Mechanical Design Coordinator
    Nejat Babür
  • Ecolab Life Sciences Unit Middle East Africa Manager
    Burcu Şeker

We hope for your participation to this important seminar focused on creating the vision for the future.

The detailed program (in Turkish) will be presented later.




PAGEV International Congress for Plastic Packaging Technologies


Third International Congress for Plastic Packaging Technologies was organized a day before Eurasia Packaging Fair, on 1st of November 2016 in Istanbul by PAGEV (Turkish Plastic Industry Foundation).

At this year's congress created with the supports of ISPE Turkey Affiliate, plastic packaging used in the pharmaceutical and cosmetic sectors was taken under the spotlight in conjunction with the congress theme of “Innovative Packaging Trends and Branding”. As a speaker, Our General Secretary Buket Hekiman Bayraktar has contributed to the pharmaceutical panel of the congress where topics such as new technologies, innovative developments, sustainability, design and branding were discussed.


International JFDA Congress

The 1st International JFDA Congress, hosted by the Jordanian Health Authority was held in Amman - Jordan on October 27-28, 2016 around the theme of "Opportunities and Future Vision for Pharmaceutical Sector”. Including Dr. Hakkı Gürsöz, the President of Turkish Medicines and Medical Devices Agency (TMMDA) and Dr. Ali Alkan, TMMDA Vice Presidency of Medicines and Pharmacy, high-order bureaucrats and health authority executives from neighboring countries have extensively participated to the congress, where Chair of ISPE Turkey Affiliate Fatma Taman had a presentation on "Risk Mitigation for Sterile Pharmaceutical Products".


Industry Gathering: “Industry 4.0”
18 October 2016


The second of “Industry Gatherings” that ISPE Turkey Affiliate organizes as afternoon meetings based on the current issues, was held on 18 October 2016 at The Grand Tarabya and covered the topic of “Industry 4.0”.

Following opening remarks of our Chair Fatma Taman, Tolga Avşar - General Manager of Scheer Turkey presented the expected changes for business life in the near future with an emphasis on the upcoming 4th industrial revolution called "Industry 4.0". The meeting continued with the speech of Ali Rıza Ersoy - Digital Factory Division Director of Siemens and he elaborated on the Industry 4.0 concept based on his knowledge and experiences that were well received by the audience.

We thank all participants and wish to meet in future Industry Gatherings which are aimed at addressing various current issues concerning the pharmaceutical industry.


“Data Integrity Key for GMP Compliance” Workshop


The second workshop of “Data Integrity Key for GMP Compliance” working group founded in 2016 within the ISPE Turkey Affiliate was held on October 14, 2016 at the facilities of Nobel İlaç Tic. ve San. A.Ş.– Ümraniye with broad participation from the pharmaceutical industry.

The workshop started with opening remarks of Hakan Şahin, General Manager of Nobel Pharmaceuticals, and the presentations of Our Chair Fatma Taman and Ulkar Holding’s Corporate Quality Manager Aysel Köker; then continued with our working group leader Figen Ergin’s presentation about Authority warning letters in connection with data integrity issues and group studies under the topics of quality control, quality assurance, production / storage and validation were performed as preliminary work towards a risk inventory.

We thank Nobel Pharmaceuticals and all our participants for their contributions and wish to meet in future workshops and seminars.


ISPE Turkey Affiliate
Industry Gathering: “Industry 4.0”
18 October 2016

The second of “Industry Gatherings” that ISPE Turkey Affiliate organizes as afternoon meetings based on the current issues, will be held on 18 October 2016 at The Grand Tarabya and will cover the topic of “Industry 4.0”.

We wish to be together at our meeting which will provide a knowledge sharing platform for "Industry 4.0" concept based on the presentations of our esteemed speakers, Tolga Avsar - General Manager of Scheer Turkey and Ali Rıza Ersoy - Deputy General Manager for Digital Factory Division of Siemens.


Date: October 18, 2016 - Tuesday
Time: 16:00-18:30
Location: The Grand Tarabya - Tarabya Hall

Program (In Turkish) | Location (In Turkish)




Turkey Affiliate Receives ISPE Affiliate of the Year Award for the Second Time

The premier pharmaceutical manufacturing event of the year, ISPE Annual Meeting was held on 18-21 September 2016 in Atlanta, USA. The Turkey Affiliate was represented by our Chair Fatma Taman, Affiliate’s Secretary General Buket Hekiman Bayraktar and Reserved Member of the Board Banu Refik. In the awards ceremony on September 20, our Affiliate was honoured by receiving the "Affiliate of the Year Award” for the service to membership and innovative contributions towards the development of the pharmaceutical industry.

The award given by Joseph Famulare, the Chairman of ISPE International Board for 2015-2016 and Michael Arnold the Chairman for 2016-2017 was received by our Chair Fatma Taman on behalf of our Affiliate, which recently celebrated its 10th year anniversary in 2015. Fatma Taman expressed our pride for getting this award for the second time after the first “Affiliate of the Year Award” that we got in 2007, only 2 years after the foundation of our Affiliate.

This important recognition achieved one more time should enhance Turkey's credibility in the global pharmaceutical platform. We are grateful to our Board and all our members for their individual contributions toward this success.

 

Click here for other News & Announcements.
Affiliate of the Year Award

10 years